VITA study

Viramune Tanzania is a study on effect of single dose carbamazepine on the pharmacokinetics of single dose nevirapine (Viramune,NVP) and development of NVP resistance, PMTCT program of Moshi, Tanzania(VITA1). The Project is being sponsored by EDCTP and collaborating with Radboud University Nijmegen Medical Centre, Zambia, University of Maimz, Germany and UK.

The primary objectives of this trial are as follows:

  1. To determine the pharmacokinetics of single dose nevirapine in HIV seroconverted pregnant women and their newborns.
  2. To determine the effect of single dose carbamazepine on the pharmacokinetics of single dose nevirapine in HIV seroconverted pregnant women and their newborns.
  3. To determine resistance against nevirapine in women before and after a single doze of nevirapine or a single doze of nevirapine/carbamazepine.
  4. Follow-up of newborns with focus on the HIV status.
  5. To examine the possible relation between nevirapine levels in cord blood and plasma ( of both mother and child) just after delivery and the HIV status of the newborn.

The secondary objective of this trial is as follows:

  • To determine the safety of single doze nevirapine and single dose nevirapine/carbamazepine.